MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for MAXI SKY 440 LE00000-EUUK manufactured by Arjohuntleigh Magog Inc..
[188484031]
On 26 february 2020 arjo was informed about event that took place in facility in (b)(6). Following information provided, the patient fell during transfer from the chair to the bed, using arjo maxi sky 440 ceiling lift and non arjo sling. In effect, the resident sustained tibial fracture, unstitched forehead laceration and facial bruise. The caregiver, who assisted the resident during transfer, said that he could have attached the sling incorrectly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2020-00016 |
| MDR Report Key | 9846530 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Facility Aware | 2020-02-26 |
| Report Date | 2020-03-18 |
| Date Reported to FDA | 2020-03-18 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXI SKY 440 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-03-18 |
| Model Number | LE00000-EUUK |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Address | 2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5 CA J1X 5Y5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-18 |